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OpenTrials
Completed

NCT Number: NCT04605640

Individualized Diet Improvement Program for Weight Loss and Maintenance, Cohort 2

This research is to develop a weight loss and weight maintenance program through dietary modifications for adults with obesity. Although scientific studies have shown the feasibility of rapid and safe dietary weight loss and subsequent weight maintenance, no efficacious dietary weight management program is widely available, and thus bariatric surgery remains the most reliable approach for weight loss/management. Safe and effective dietary weight loss and subsequent weight maintenance require flexible, individualized advice by an experienced dietitian/nutritionist.

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Key information

Conditions

Obesity Behavior Behavior, Animal Body Weight Body Weight Changes Diet Habit Feeding Behavior Nutrition Disorders Nutritional and Metabolic Diseases Overnutrition Overweight Pathological Conditions, Signs and Symptoms Signs and Symptoms Weight Loss

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Illinois at Urbana-Champaign

Urbana, Illinois, 61801, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

body mass index in the overweight or obese range (BMI) >28 kg/m2 (if Asian, BMI >25kg/m2); not currently pregnant or lactating; have Wi-Fi at home, a working email, and an iPhone or Android smartphone; no self-reported severe metabolic, cardiovascular or musculoskeletal disease; not using insulin injection; able to attend the 22 (1 hour) diet improvement sessions; willing to lose 20 lb. or more for 6 months and maintain a healthy weight for one year; keep weighing their weight for two years; fluent in reading and writing English.

Exclusion criteria

age <18 or >70 years; body mass index of <28 kg/m2 (if Asian, BMI <25kg/m2); currently pregnant; currently lactating; self-reported with severe metabolic, cardiovascular, or musculoskeletal disease; use insulin injection; not able to attend the 22 (1 hour) diet improvement sessions for 1 year; failed to set up a Wi-Fi scale; failed to submit a FFQ.

Treatment and study plan

Weight Management Intervention

Behavioral

Participants attend group and individual dietary education sessions. Participants create a diet plan that satisfies their needs. Participants aim to lose 1 pound weekly until a BMI of 25 is reached. Participants are evaluated through daily self-weighing, dietary records, and food frequency questionnaires.

Primary outcomes

  1. Body weight

    Time frame: Change from baseline (0 month) to 6 month, 12 month, 18 month, and 24 month

    Body weight in kilograms measured on a standard scale (Withings, US)

Secondary outcomes

  1. Waist circumference

    Time frame: Change from baseline (0 month) to 6 month, 12 month, 24 month

    Waist circumference in centimeters measured using a standard measuring tape

  2. Hip circumference

    Time frame: Change from baseline (0 month) to 6 month, 12 month, 24 month

    Hip circumference in centimeters measured using a standard measuring tape

  3. Body composition

    Time frame: Change from baseline (0 month) to 6 month, 12 month, 24 month

    Body fat measured using InBody 270

  4. Body composition

    Time frame: Change from baseline (0 month) to 6 month, 12 month, 24 month

    muscle mass measured using InBody 270

  5. Protein intake

    Time frame: Change from baseline (0 month) to 12 month

    Protein intake in grams and grams/100 kilo-calories using a food frequency questionnaire (FFQ)

  6. Protein intake

    Time frame: Periodically from baseline (0 month) to 12 month

    Protein intake in grams and grams/100 kilo-calories using a 24-hour dietary record

  7. Fiber intake

    Time frame: Change from baseline (0 month) to 12 month

    Fiber intake in grams and grams/100 kilo-calories using a food frequency questionnaire (FFQ)

  8. Fiber intake

    Time frame: Periodically from baseline (0 month) to 12 month

    Fiber intake in grams and grams/100 kilo-calories using a 24-hour dietary record

Sponsors and collaborators

Lead sponsor

University of Illinois at Urbana-Champaign

Other

Registry information

Official study title

Individualized Diet Improvement Program for Weight Loss and Maintenance

Acronym: iDIP

Important dates

Study start
2019
Primary completion
2021
Study completion
2021
First posted
Oct 28, 2020
Registry last updated
Jul 23, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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